Benzinga.com1mon
Neuralink's 'Blindsight' Device Receives FDA Breakthrough Designation
Elon Musk’s brain-chip company Neuralink has received the FDA's “breakthrough device” designation for its experimental vision-restoring implant, Blindsight. The designation, announced on ...
FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDADENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- ...
pharmaphorum6d
Janssen's ibrutinib receives two oncology FDA Breakthrough Therapy Designations
Janssen, a subsidiary of J&amp,J, together with Pharmacyclics, have announced that the FDA has granted two Breakthrough Therapy Designations to the investigational oral agent ibrutinib that the ...
Seeking Alpha22d
Sagimet Soars: FDA Breakthrough Therapy Designation And Lancet Review Validate Denifanstat
Sagimet Biosciences' Denifanstat shows significant potential in treating MASH, with FDA Breakthrough Therapy designation and peer-reviewed validation, supporting a "Strong Buy" rating. Denifanstat ...
Business Insider1mon
Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide
The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis ...
MarketWatch1mon
Ultragenyx Pharmaceutical's Bone Disease Drug Gets FDA's Breakthrough Therapy Designation
The breakthrough therapy designation allows the company to speed up the development and review of drugs which can help treat serious conditions. The FDA's decision as based on preliminary clinical ...
Morningstar1mon
Biogen Gets FDA Breakthrough Designation for Kidney-Transplant Drug
Biogen said it won Food and Drug Administration breakthrough-therapy designation for its proposed treatment for a major cause of kidney-transplant failure. The Cambridge, Mass., biotechnology ...
MarketWatch1mon
Mirum Pharmaceuticals' Volixibat Gets Breakthrough Therapy Designation from FDA
Mirum Pharmaceuticals's volixibat was granted breakthrough therapy designation by the Food and Drug Administration as a potential treatment for cholestatic pruritus for those with primary biliary ...
Business Wire1mon
AccurKardia Receives FDA Breakthrough Device Designation for First-of-its-Kind Aortic Valve Stenosis ECG-based AI Screening Software
For a diagnostic tool to qualify for FDA Breakthrough Device Designation, it must provide more effective diagnosis of life-threatening conditions, represent a breakthrough in technology ...
Yahoo Finance1mon
Ultragenyx Receives Breakthrough Therapy Designation for Setrusumab (UX143) in Osteogenesis Imperfecta
"FDA designation of setrusumab as a Breakthrough Therapy emphasizes the seriousness of osteogenesis imperfecta and the impact of this disease on people and their families affected by this disorder ...
Yahoo Finance1mon
Volixibat Granted Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis
The FDA’s Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat serious or life-threatening diseases. To qualify for this designation ...
Business Wire1mon
Volixibat Granted Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to volixibat as a potential treatment for cholestatic pruritus in patients with ...